MAUDE Adverse Event Report: NDC HOMECARE LLC MEDIFLO; PUMP, INFUSION, ELASTOMERIC

Model Number MDC270050

Patient Problem Chemical Exposure (2570)

Event Date 01/17/2024

Event Type  malfunction  

Event Description

Middle-aged male with history of gastrohepatic lymphadenopathy.Procedure: chemo treatment per 5fu ball.Patient (pt) was receiving 5fu treatment per ball and was over 24 hours into treatment.Pt was sleeping and when awoke, noticed that the elastomeric ball was leaking.Patient placed a plastic bag around ball and came to infusion therapy.Infusion therapy reported that the ball was empty.It was not known the amount of medication was received.Patient¿s areas of exposure were cleaned and clothing discarded.Unknown harm to patient at this time.Manufacturer response for pump, infusion, elastomeric, mediflo (per site reporter).Reported by pharmacist.

• Brand Name: MEDIFLO
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): NDC HOMECARE LLC; 402 bna drive; suite 500; nashville TN 37217
• MDR Report Key: 18621365
• MDR Text Key: 334309088
• Report Number: 18621365
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00850007185022
• UDI-Public: (01)00850007185022(10)C23G067(17)260603(11)230703
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: MDC270050
• Device Catalogue Number: MDC270050
• Device Lot Number: C23G067
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/23/2024
• Event Location: Home
• Date Report to Manufacturer: 02/01/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/01/2024
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 15695 DA
• Patient Sex: Male
• Patient Weight: 156 KG